BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT VITA METER

    MDR report key: 1924640 · Received December 14, 2010

    Report

    Report Number
    2939301-2010-10712
    Event Type
    Injury
    Date Received
    December 14, 2010
    Date of Event
    November 28, 2010
    Report Date
    November 29, 2010
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    LIFESCAN (LFS) HAS REQUESTED RETURN OF THE SUBJECT PRODUCT(S) FOR EVALUATION. IF THE PRODUCT(S) ARE RETURNED, LFS WILL EVALUATE IT/THEM AND INFORM FDA OF PRODUCT(S) THAT DO NOT PASS INSPECTION IN A SUPPLEMENTAL REPORT. A 510(K) # IS K082513.

    Description of Event or Problem · 1

    ON (B)(6) 2010 THE LAY USER/ PATIENT CONTACTED LIFESCAN (LFS) ALLEGING THAT HIS ONETOUCH VITA METER WAS NOT POWERING ON. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE PATIENT REPORTED THE ALLEGED ISSUE BEGAN ON (B)(6) 2010 AT AN UNSPECIFIED TIME. THE PATIENT INFORMED THE CCA THAT HE MANAGES HIS DIABETES WITH INSULIN (NO ADJUSTMENTS). DESPITE THE ALLEGED ISSUE, THE PATIENT DENIED TAKING ANY ACTION REGARDING HIS DIABETES MANAGEMENT ROUTINE. ON THE SAME DAY IN THE AFTERNOON, THE PATIENT CLAIMED HE WAS FEELING HYPOGLYCEMIC, FAINTY, AND SWEATY AFTER THE ALLEGED ISSUE BEGAN. THE PATIENT HOWEVER DENIED RECEIVING ANY MEDICAL TREATMENT AS A RESULT OF THE ALLEGED SYMPTOMS. AT THE TIME OF TROUBLESHOOTING, THE CCA WAS ABLE TO VERIFY THIS WAS NOT THE FIRST TIME THE PRODUCTS HAD BEEN USED, THERE WAS NO MISUSE OF THE SUBJECT METER, THE CORRECT TEST STRIPS WERE USED, AND THE METER DID NOT NEED NEW BATTERIES. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT WAS NOT UNABLE TO TEST HIS BLOOD GLUCOSE AND REPORTEDLY DEVELOPED SYMPTOMS SUGGESTIVE OF A SERIOUS INJURY AFTER THE ALLEGED METER ISSUE BEGAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT VITA METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN INC. 2992640

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Life Threatening